DGAP-News: MOLOGEN AG: Cooperation with amfAR Institute for HIV Cure Research on clinical combination trial

PRESS RELEASE N 18 / 2019 of 10/08/2019

MOLOGEN AG: Cooperation with amfAR Institute for HIV Cure Research on clinical combination trial

Berlin, 8 October 2019 - The biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900, SIN A2L Q90) today announced the cooperation with the renowned UCSF (University of California, San Francisco)-based amfAR (American Foundation for AIDS Research) Institute for HIV Cure Research on a clinical combination trial. In the planned investigator-initiated trial, a novel combination treatment will be evaluated: Following administration of an HIV vaccine strategy, a combination of the TLR9 agonist lefitolimod and two potent broadly neutralizing antibodies (bNAbs) to HIV-infected adults receiving antiretroviral therapy (ART). This treatment strategy will be followed by interruption of ART and allow researchers to evaluate if this combination can lead to durable control of HIV in absence of a therapy. The study is planned as a cooperation of the amfAR Institute of HIV Cure Research, UCSF, the Division of AIDS (DAIDS) at National Institute of Allergy and Infectious Diseases/National Institute of Health (NIAID/NIH) and several other partners. The trial will be conducted in the US and is expected to start in 2019.

Dr Matthias Baumann, CMO of MOLOGEN AG, commented "This study is supporting our new strategy with focus on combination therapies with our TLR9 agonists and other immunotherapeutic agents in the indications oncology and HIV."

"Our goal is to achieve a period of remission off ART, which would be a major step in the direction of complete eradication.", HIV cure pioneer, professor of medicine at UCSF and the study's Principal Investigator, Dr Steven Deeks, states, "Due to the carefully selected combination strategy, we might be able to induce a delay in viral rebound based on immunological control of HIV by the immune system."

The design of the trial is based on the findings of the phase I/IIa TEACH trial in HIV, which, as well, was financed by amfAR and conducted in cooperation with Aarhus University Hospital, Denmark. An additional study in HIV is about to start: the phase IIa TITAN combination study, for which Gilead Sciences, Inc. is providing the funding. The study is a collaboration between MOLOGEN and Aarhus University Hospital, Denmark, including additional international sites. In this trial, the TLR9 agonist lefitolimod will be evaluated in combination with innovative, virus-neutralizing antibodies developed and supplied by Rockefeller University, New York, USA.

MOLOGEN AG
MOLOGEN AG is a German biopharmaceutical Company and a pioneer in the field of immunotherapy on account of its unique active agents and technologies. Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the treatment of HIV and infectious diseases.

The focus of MOLOGEN's development is on DNA-based TLR9 agonists, where it has consistently been ahead of the course. This includes the lead compound, the immunotherapy lefitolimod, and its next generation molecules EnanDIM^(R), building the foundation for a next generation immunotherapy platform in areas of unmet need.

Forthcoming milestones include: the start of the TITAN study in HIV, the start of the clinical development of EnanDIM^(R) and additional combination studies in cancer, including one with our strategic partner Oncologie Inc., which are in an advanced planning stage.

MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares (ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the German Stock Exchange.

www.mologen.com

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Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.